Regulatory Affairs Engineer – Medical Devices (Electronics & Mechanical)
Location: Hyderabad (On-site)
Company: PlebC Innovations Pvt Ltd
Employment Type: Full-Time
Experience Level: Open to Freshers and Experienced Candidates (0–5 years)—compensation commensurate with experience.
About the Company
PlebC Innovations is a deeptech startup developing TORUS (Tele-Operated Robotic Ultrasound System). Our mission is to bridge the healthcare gap in remote and underserved areas by enabling "Diagnosis from a Distance.
About the Role
We're hiring our first dedicated regulatory affairs engineer to build out regulatory documentation and quality processes alongside our engineering teams as the product moves toward submission-readiness. This is a hands-on, build-it-yourself role — you'll work directly with the founding/technical team rather than within an existing QA/RA department, with full ownership of the regulatory function as it's established at PlebC.
Key Responsibilities
Prepare, review, and maintain regulatory documentation for TORUS as it moves through design and V&V.
Build and maintain Design History File (DHF), Device Master Record (DMR), Technical File, and Risk Management File — largely from scratch, in collaboration with engineering teams.
Support compliance activities related to:
- ISO 13485 (Quality Management Systems)
- ISO 14971 (Risk Management)
- IEC 60601 Series (Electrical Safety)
- IEC 62304 (Software Lifecycle)
- IEC 62366 (Usability Engineering)
- MDR (EU Medical Device Regulation)
- CDSCO Medical Device Rules (India)
- FDA 21 CFR Part 820 (Quality System Regulation)
Coordinate directly with Mechanical, Electronics, Embedded, and Software teams to collect design evidence and verification records.
Create and maintain:
- Requirements Traceability Matrix (RTM)
- Verification & Validation Reports
- Risk Analysis Documents (FMEA, Hazard Analysis)
- SOPs and Work Instructions
- Test Protocols and Test Reports
- Clinical Evaluation support documentation
- Help establish document control and version management practices (these are still being built out — you'll have input on how they're structured).
- Support internal audits and prepare for future external/regulatory audits.
- Participate in design reviews and change control activities
What to Expect in This Role
Because this is PlebC's first regulatory hire, you should expect to:
- Define and propose processes rather than inherit fully mature ones.
- Work closely and directly with the founder/CTO for guidance, escalation, and decisions — not a layer of RA managers.
- Have real influence over how TORUS's regulatory pathway is shaped, with the responsibility that comes with that.
- Be comfortable with ambiguity in the early months while documentation systems and SOPs are still being established.
Required Qualifications
- Bachelor's Degree in: Biomedical Engineering, Electronics & Communication Engineering, Mechanical Engineering, Mechatronics Engineering, Medical Electronics, or related disciplines.
- Freshers with strong regulatory coursework or academic projects are encouraged to apply.
- Experienced candidates with medical device regulatory experience are equally encouraged — compensation will reflect experience level.
Required Skills
- Understanding of the medical device development lifecycle.
- Knowledge of mechanical and electronic systems integration.
- Familiarity with risk management methodologies (FMEA, Hazard Analysis).
- Strong technical documentation and report-writing skills.
- Ability to read engineering drawings, schematics, and technical specifications.
- Knowledge of quality management systems and document control practices.
- Excellent communication and cross-functional collaboration skills — you'll need to work across disciplines without a regulatory team behind you for backup.
- Comfort working independently and proactively in a function that's still being defined.
Preferred Skills
- Experience with Class B/Class C medical devices.
- Exposure to robotic systems, ultrasound devices, or healthcare products.
- Familiarity with design controls and regulatory submissions.
- Knowledge of cybersecurity and software validation requirements (relevant given TORUS's tele-operated, networked architecture).
- Experience with ISO audits and compliance reviews.
Pay: ₹240,000.00 - ₹500,000.00 per year
Ability to commute/relocate:
- Gachibowli, Hyderabad, Telangana: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- Have you worked on ISO 13485 documentation?
- Have you prepared DHF, DMR, Risk Management Files, or Technical Files?
- Do you have experience with IEC 60601, ISO 14971, or FDA 21 CFR 820?
- Have you worked with both electronic and mechanical product documentation?
Work Location: In person
